Acceptability of microbiota-directed complementary foods in treating Indian children with moderate acute malnutrition - eACT-MAM pre-proof of concept study.

Abstract

Background: In India, currently, there are no standard guidelines for the management of moderate acute malnutrition (MAM). Previous research in Bangladesh has shown that children with MAM have impaired gut microbiota development, and microbiota-directed complementary foods (MDCF) can potentially repair their gut microbiota.

Objectives: To evaluate the acceptability and safety of supplementing shelf-stable formulation of MDCF in Indian children with MAM as compared to a locally prepared ready-to-use supplementary food (RUSF) in three geographically distinct Indian populations and to establish and pilot systems of intervention delivery, collection, transport and storage of stool samples using stringent protocols.

Methods: This pre-proof of concept (prePOC), multicentric, open-labelled, age-stratified, randomised controlled trial was done in children aged 6-18 months with MAM. After a run-in period of 2 weeks, the participants were supplemented with MDCF or RUSF for 4 weeks through direct observation and followed up for another 2 weeks post intervention. Maternal responses to the acceptability of the organoleptic properties of supplements were recorded weekly during the intervention phase of 4 weeks. Compliance was reported based on the amount of supplement consumed by the children. Feasibility of weekly stool sample collection (except seventh week) within 30 minutes of passage was recorded. Anthropometric measurements were done at baseline and endline. Monitoring for adverse events was done throughout the course of the study.

Results: A total of 240 children with MAM were randomised to receive either MDCF or RUSF, of which 221 (92.1%) completed follow-up. The overall acceptability for more than 80% of the maternal responses was reported as good or very good for all organoleptic properties in both MDCF and RUSF arms. MDCF and RUSF interventions had good-to-high compliance in 83.0 % and 79.8% of participants, respectively. At the end of the intervention phase, 53.2% (58/109) children in MDCF arm against 42.0% (47/112) in RUSF arm had weight-for-length Z score >-2. The overall incidence of acute gastroenteritis reported was low; higher in MDCF compared to RUSF but not statistically significant.

Conclusion: The prePOC study demonstrates good acceptability and safety of MDCF amongst Indian children with MAM including the age group of 6-12 months of age. The study demonstrates feasibility to conduct a long-term supplementation study in this population.

Trial registration: Clinical trial registry of India (CTRI/2023/01/048716) STATEMENT OF SIGNIFICANCE: This study tested the acceptability and safety of MDCF in the Indian population and demonstrated the same in the 6 to <12 months age category, where it has not been tested elsewhere.